Philips Recalls Velara Generators Due to Potential System Lockup
Philips is recalling 59 Velara Generators used with Allura Xper Systems because the devices may lock up. The recall is voluntary and covers units in the US and internationally.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (system lockup) where no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Philips Electronics North America Corporation is voluntarily recalling 59 Velara Generators equipped with an old firmware version. These generators are used with specific Philips Allura Xper Systems, including the Allura 15 & 12 (monoplane), Allura FD10C, Allura FD10F, Allura FD 10 F/C, Allura FD20, Allura XPER FD10/10, and Allura XPER FD20 Biplane. The recall was initiated on December 9, 2016, and was terminated on July 30, 2020.
The reason for the recall is that the system may lock up. The affected devices are identified by specific 12nc numbers: 989000070011, 989000070122, 989000070123, 989000070124, 989000070125, 989000070126, and 989000070321. The FDA classified this recall as Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The affected units were distributed in the United States (AL, CA, DC, IL, GA, KS, MD, MO, NC, NY, OH, PA, RI, SC, TX, WA) and internationally (Brazil, Bulgaria, Costa Rica, France, Germany, Israel, Italy, Japan, Korea, Republic of, Mexico, Russian Federation, Singapore, Spain, Sweden, Switzerland, Turkey, United Kingdom). Users should check their device's 12nc number against the list provided by Philips to determine if their unit is affected.
The recalled product
- Product
- Velara Generator with an old Firmware version used with Philips Allura Xper Systems (Allura 15 & 12 (monoplane), Allura FD10C, Allura FD10F, Allura FD 10 F/C, Allura FD20, Allura XPER FD10/10, Allura XPER FD20 Biplane)
- Manufacturer
- Philips Electronics North America Corporation
- Hazard
- Affected units
- 59
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Velara Generator with 12nc number: 989000070011
- 989000070122
- 989000070123
- 989000070124
- 989000070125
- 989000070126
- 989000070321
Distribution
Part of a larger recall action
This product is one of 2 recalled by Philips Electronics North America Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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